The final phase 3 analysis of Covaxin, the Covid-19 jab developed by Bharat Biotech, has shown the efficacy of 78 per cent in preventing symptomatic coronavirus caused disease, a report said.
Officials familiar with the development said that the Hyderabad-based vaccine maker is likely to announce the results in June.
As per previous reports, while the first interim efficacy analysis had shown the efficacy of nearly 81 per cent, the second interim analysis results showed it to be about 78 per cent.
Dr Sanjay Rai, professor, community medicine department, All India Institute of Medical Sciences (AIIMS), Delhi told Hindustan Times: “The final analysis was done at 130 confirmed case and it was found to be 78 per cent.”
“The interim analysis may be over, the analysed data needs to be peer-reviewed and published in a medical journal now,” added Dr Rai who is also the principal investigator of the study site at AIIMS.
While confirming the news about the vaccine, another official in the central government said: “We have been made to understand that the interim analysis results for Covaxin phase 3 trials are almost done and they are in the process of publishing the data.”
This analysis comes at a time when Bharat Biotech has applied for emergency use listing (EUL) from the World Health Organization (WHO) and the company is expecting a nod from the UN health agency by July-September.
The researchers have analysed Covaxin’s efficacy at several, pre-set interval—known as endpoints.
The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 per cent.
The results were released in March 2021.
The second interim analysis result, released in April, was based on accruing more than 87 symptomatic Covid-19 cases.
It showed that the efficacy of the vaccine against the coronavirus caused disease was 100 per cent and a reduction of hospitalization numbers was also noted.
Even though Bharat Biotech has not yet revealed any details about the final analysis, in April the company said that the safety and efficacy details will be available by June.
The vaccine maker also stated that the final results will be submitted to a peer-reviewed publication.
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